MAUDE Adverse Event Report: NEOTRACT, INC. UROLIFT UL2 ATC IMPLANT CARTRIDGE; IMPLANTABLE TRANSPROSTATIC TIS

Catalog Number	UL2ATC-C
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported " noticed throughout the procedure cartridges were slightly more difficult to insert but still seemed to be locking in properly.Before placing the 6th implant, the delivery system needed to be reset.It seemed like the trigger hadn't been fully retracted after last implant delivery.Physician successfully inserted atc cartridge into delivery system and attempted placement on patients left proximal slightly anterior to first proximal implant.After retracting needle/3rd pull the keyhole showed metal that looked like the needle, not a ct or ue.Successfully removed delivery system but the tip of delivery system showed the needle was broken in half.We used vo to look inside patient and saw needle tip floating at the base of the bladder.Physician used a grasper to remove tip of needle through rigid cysto sheath.Patient had some irritation to the bladder wall from needle which resulted in placement of a catheter.Patient had catheter removed next day and does not report any additional concerns".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported " noticed throughout the procedure cartridges were slightly more difficult to insert but still seemed to be locking in properly.Before placing the 6th implant, the delivery system needed to be reset.It seemed like the trigger hadn't been fully retracted after last implant delivery.Physician successfully inserted atc cartridge into delivery system and attempted placement on patients left proximal slightly anterior to first proximal imlant.After retracting needle/3rd pull the key hole showed metal that looked like the needle, not a ct or ue.Successfully removed delivery system but the tip of delivery system showed the needle was broken in half.We used vo to look inside patient and saw needle tip floating at the base of the bladder.Physician used a grasper to remove tip of needle through rigid cysto sheath.Patient had some irritiation to the bladder wall from needle which resulted in pla cement of a catheter.Patient had catheter removed next day and does not report any additional concerns".

• Brand Name: UROLIFT UL2 ATC IMPLANT CARTRIDGE
• Common Device Name: IMPLANTABLE TRANSPROSTATIC TIS
• Manufacturer (Section D): NEOTRACT, INC.; pleasanton
• Manufacturer (Section G): NEOTRACT, INC.; 4155 hopyard road; pleasanton
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23594425
• Report Number: 3015181082-2025-00060
• Device Sequence Number: 21215587
• Product Code: PEW
• UDI-Device Identifier: 10814932020459
• UDI-Public: (01)10814932020459(11)250706(17)270706(10)73G2500079(21)
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K232558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: UL2ATC-C
• Device Lot Number: 73G2500079
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown